Clinical Study to Assess the Efficacy and Pressure Maintenance of MOBIDERM Autofit Versus Bandages in the Management of Breast Cancer Related Lymphedema (BCRL) in Night-time Maintenance Phase.
Starting soon · Not applicable
Conditions studied: Limb Lymphoedema
In brief
The aim of this cross-over, randomized study is to assess the efficacy and pressure maintenance of MOBIDERM Autofit versus bandages in the management of Breast Cancer Related Lymphedema (BCRL) in night-time maintenance phase.
Key facts
- Study ID
- NCT07355959
- Run by
- Thuasne
- People needed
- 16
- Starts
- 2026-01-15
- Expected to finish
- 2026-07-01
- Last updated by the study team
- 2026-01-29
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years
- Unilateral upper limb lymphedema of stage I, II or III according to the criteria defined by the International Society of Lymphology, following breast cancer
- Patient in maintenance phase of lymphedema treatment
- Affected arm that fits with one of the standard sizes of the Auto- Adjustable MOBIDERM Autofit provided.
- Signed informed consent prior to any study-mandated procedure.
You may not qualify if…
- Active cellulitis / Infectious dermo-hypodermatitis
- Lymphedema associated with active cancer needing acute chemotherapy
- Motor and sensitive neurological deficiency / psychiatric or addictive disorders
- Patients for whom compression is contraindicated, such as untreated infections, skin irritation, thrombosis: presence of skin lesions on the sleeve placement
- Pregnant or breastfeeding patient
- Participation to any other clinical study which has an impact on the different endpoints
- Vulnerable patient, adults being the object of a legal protective measure or enable to express their consent.
Where it is running
- Ödemzentrum Bad Berleburg Klinik — Bad Berleburg, Germany
Full record on ClinicalTrials.gov
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